BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILAS LASER SYSTEM

    MDR report key: 7131351 · Received December 19, 2017

    Report

    Report Number
    3008252121-2017-00004
    Event Type
    Malfunction
    Date Received
    December 19, 2017
    Date of Event
    November 8, 2017
    Report Date
    January 23, 2018
    Manufacturer
    OD-OS GMBH
    Product Code
    GEX
    PMA / PMN Number
    K162191
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE NAVILAS LASER SYSTEM WAS RETURNED TO OD-OS GMBH, CLEANED, DECONTAMINATED, AND EVALUATED. THE FINAL INVESTIGATION CORROBORATED THE RESULTS FROM THE INITIAL INVESTIGATION WHERE THE INVALID CALIBRATION WAS REPRODUCED, MEASURED, AND CONFIRMED. THE ACTUAL LASER MISPLACEMENT WAS EQUIVALENT TO THE THEORETICAL CALCULATION. IN ADDITION, THE OPTICAL HEAD WAS SUBJECTED TO COMPREHENSIVE TESTING AND NO MECHANICAL FAULTS WERE IDENTIFIED. THE SYSTEM WAS REPAIRED AND RECALIBRATED AND PASSED FINAL INSPECTION TESTING. IN CONCLUSION, THE DEVICE MALFUNCTION WAS CONFIRMED TO BE SOLELY ATTRIBUTED TO INVALID CALIBRATION PERFORMED BY FOREIGN SERVICE PERSONNEL. MANUFACTURER'S COMPLAINT #: (B)(4).

    Additional Manufacturer Narrative · 1

    BASED ON REVIEW OF THE SYSTEM LOG FILES AND 2 SIMILAR COMPLAINTS ON THIS LASER SYSTEM, OD-OS HAS CONCLUDED THAT THIS IS THE SAME FAILURE MODE OF INVALID CALIBRATION, WHICH CAN RESULT IN TREATMENT BEING DELIVERED TO AN UNINTENDED AREA OF THE RETINA. THE INITIAL INVESTIGATION (BASED ON FIELD INVESTIGATION OF THE LASER SYSTEM AND REVIEW OF MANUFACTURING DEVICE HISTORY RECORDS) REVEALED THAT THE ROOT CAUSE WAS FOUND TO BE AN INVALID CALIBRATION OF THE DEVICE BY THE SERVICE TECHNICIAN. THE DEVICE IS BEING RETURNED TO OD-OS AND THE FINAL INVESTIGATION FINDINGS WILL BE REPORTED IN A FOLLOW-UP REPORT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS PROVIDED BY THE RETINA SPECIALIST, WHO REPORTS THAT THE DEVICE MALFUNCTION HAD NO ADVERSE EFFECT ON THE PATIENT'S HEALTH.

    Description of Event or Problem · 1

    THE MANUFACTURER BECAME AWARE OF A DEVICE MALFUNCTION DURING A REVIEW OF THE LASER SYSTEM DATA. THIS RECORD REVIEW REVEALED THAT ON (B)(6) 2017 A PATIENT UNDERWENT ATTEMPTED LASER PHOTOCOAGULATION IN THE RIGHT EYE TO TREAT MICROANEURYSMS IN THE CENTRAL RETINA. DURING THE PROCEDURE, THE TREATMENT WAS NOT DELIVERED TO THE TARGET AREA. IT WAS SUSPECTED THAT INVALID CALIBRATION OF THE LASER SYSTEM LED TO MISPLACED TREATMENT. OD-OS CONTACTED THE TREATING PHYSICIAN ABOUT THIS PATIENT AND HE WAS ABLE TO CONFIRM THAT THERE WAS NO LASER TREATMENT DELIVERED TO THE TISSUE INTENDED TO BE TREATED. THE PHYSICIAN EXAMINED THE PATIENT POSTOPERATIVELY AND CONFIRMED THERE WAS NO DAMAGE TO THE FOVEA, MACULA, OR RETINA, NO LOSS OF BCVA, AND NO INTERVENTION REQUIRED. THE RETINAL IMAGES AND LASER SETTINGS WERE REVIEWED BY THE OD-OS MEDICAL MONITOR (RETINA SPECIALIST). THE LASER SETTINGS USED WOULD NOT BE EXPECTED TO PRODUCE RETINAL EFFECTS DUE TO THE VERY LOW POWER DENSITY SELECTED (APPROXIMATELY 8 TIMES BELOW TYPICAL) AND THE VERY SHORT PULSE DURATION (APPROXIMATELY 5 TIMES BELOW TYPICAL). BASED ON THESE SETTINGS, NO RETINAL INJURY WOULD BE ANTICIPATED AND NONE WERE SEEN ON THE POSTOPERATIVE RETINAL IMAGES FROM (B)(6) 2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    910732 NAVILAS LASER SYSTEM POWERED LASER SURGICAL INSTRUMENT GEX OD-OS GMBH 577S

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR